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NCT02097849 · ClinicalTrials.gov registry record · Phase 2
Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
A Phase 2 study of Relapsing Forms of Multiple Sclerosis, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 14
- Study locations
NCT02097849 is a Phase 2 study of Relapsing Forms of Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 71 participants. The trial reports 14 study locations across 10 states.
The verdict
NCT02097849, a Phase 2 study of Relapsing Forms of Multiple Sclerosis, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 14
- Study locations
Study Summary
Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN). Secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) \[a mostly T cell-independent humoral response\] and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) \[T cell-dependent neoantigen response\].
Conditions Studied
Interventions
- DRUG dimethyl fumarate
- BIOLOGICAL tetanus diphtheria toxoids vaccine
- BIOLOGICAL 23-valent pneumococcal polysaccharide vaccine
- BIOLOGICAL meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)
- DRUG non-pegylated interferon
Study Locations (14)
Ohio
- Research Site - Akron
- Research Site - Cleveland
- Research Site - Dayton
Florida
- Research Site - Fort Lauderdale
- Research Site - Sarasota
Texas
- Research Site - Round Rock
- Research Site - San Antonio
Arizona
- Research Site - Gilbert
Colorado
- Research Site - Thornton
Indiana
- Research Site - Indianapolis
Kentucky
- Research Site - Lexington
Maine
- Research Site - Auburn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2015-02-28 |
| Est. Completion | 2016-05-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02097849
The ClinicalTrials.gov registry entry for NCT02097849 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Relapsing Forms of Multiple Sclerosis appearing as the primary indexed condition, and to 5 interventions - of which dimethyl fumarate is the first listed.
NCT02097849 reports 14 study locations spanning 10 distinct geographic areas - top geographies include Ohio, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT02097849 about?
NCT02097849 is a clinical study titled "Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.". Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN). Secondary objecti...
What is the current status of trial NCT02097849?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2015-02-28. Estimated completion is 2016-05-02.
What conditions does trial NCT02097849 study?
This clinical trial studies the following conditions: Relapsing Forms of Multiple Sclerosis.
What interventions are being tested in trial NCT02097849?
The interventions under investigation include: dimethyl fumarate (DRUG), tetanus diphtheria toxoids vaccine (BIOLOGICAL), 23-valent pneumococcal polysaccharide vaccine (BIOLOGICAL), meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) (BIOLOGICAL), non-pegylated interferon (DRUG).
Who is sponsoring clinical trial NCT02097849?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02097849 being conducted?
This trial has 14 study locations across Arizona, Colorado, Florida, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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